Body WeightWFPBmuscleNCT04849689
WFPB Lifestyle and Muscle Mass Preservation
An observational study of Body Weight and Body Image, run by Barbara Jakše s.p. at 1 site in Slovenia.
Trial summary
Body fat (BF) and muscle mass showed opposing association with mortality. Whole-food, plant-based (WFPB) lifestyle programs has been on the rise lately especially due to impressive health benefits. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Body Weight, Body Image, Body Weight Changes
- What is being tested?
- Whole-food, plant-based lifestyle
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 217 participants
- Where
- 1 siteSlovenia
- Study dates
- 12 Apr 2021to 23 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will examine the body composition data of healthy adults from Slovenia (European Union) that were without preference toward plant-based diet before entering to the program. As healthy adults we mean that used data were from participants without serious comorbidities (i.e., having autoimmune or neurodegenerative disorders), physical limitations or taking medicine (for blood pressure, blood sugar or cholesterol).
Who may be able to join
- Using WFPB lifestyle program.
- Were measured on a body composition analyzer at least two successive times on the same body composition montor Tanita 780 S MA, Tokyo, Japan (at baseline, follow up) in a row at different intervals (i.e., before the start of the program and as part of follow up).
- Follow up up to 6 months
- Baseline BMI status was not an exclusion criteria.
- Data of participants that did not participate yet in our previous research.
- No medication use
- If the individual performed more than two consecutive measurements, only the first two were included in the analysis.
Who cannot join
- Being on vegan diet before joined in our program.
- Being adult (e.g., older than 18-years) before the start of the program.
- Participating in our preivous research using WFPB lifestyle program.
- Without severe chronic diseases or physical limitations (described bellow).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Whole-Food, Plant-Based Lifestyle Program Preserves Muscle Mass During Body Mass/Fat Mass Loss
Body fat (BF) and muscle mass showed opposing association with mortality. Whole-food, plant-based (WFPB) lifestyle programs has been on the rise lately especially due to impressive health benefits.
The results of research on the effectiveness of popular weight loss diets in obese subjects showed 20 to 30% loss of lean muscle mass within to the total body weight loss, whereas in the whole-food, plant-based (vegan) diet the loss was up to 42%.
Read more
Therefore, an open research problem is to find a way how to improve body composition in an effective and healthy way (i.e., losing of excess BF while maintaining muscle mass as much as possible) but still using stric plant-based (vegan) diet.
Investigators will perform retrospective analysis of measurements of body composition and phase angle values of aprox. 200 participants who were on a WFPB lifestyle program from 2016 to 2021 and performed two successive measurements (initial and follow up (FU)), without body mass index (BMI) limitation on same medically approved and calibrated bioelectrical impedance (Tanita 780 S MA, Tokyo, Japan) and were not yet included in our previous studies. A WFPB lifestyle program were consisted of nutrition (i), (ii) physical activity and (iii) support system.
Primary outcome include the following measures: BF % and FFM and to examine the change from initial values to FU values (by gender), according BMI classification (e.g,, normal, pre-obese and obese) with subanalysis for those participants who lost up to 5 kg/more and those who lost 5 kg or more of body weight.
Read the detailed description
Many people are increasingly using a variety of dietary practices to manage overweight and obesity. Many people are increasingly using a variety of dietary practices to manage overweight and obesity.
Investigators will investigate the muscle mass preservation of participants on our 12-year lasting ongoing, community-based (free-living), WFPB lifestyle program during the weight/fat loss of participants.
The primary outcome is the BF %, and FFM change from initial values to FU values (for whole sample and by gender).
Secondary outcome include correlation between BMI, BF % and FFM, and PhA. Based on our experiences we believe that some participants that follow our WFPB lifestyle program may initially "afraid" to eat, according to the instructions, each meal to satiety (ad libitum). The reason lies in the typical weight loss recommendation in Western-type lifestyle that advise "eating less".
The body composition measures will include body height (BH; measured via standardized medical approved professional personal floor scale with stand (Kern, MPE 250K100HM, Kern \& Sohn, Balingen, Germany), body mass (BM), BF mass and BF %, FFM, bone mineral mass (BMM), visceral fat (VF), total body water (TBW), extracellular water (ECW), intracellular water (ICW), the ratio, whole body phase angle (PhA), all via medically approved and calibrated bioelectrical impedance Tanita 780 S MA (Tanita Corporation, Tokyo, Japan) and the use of corresponding protocols (e.g., for BMI).
- Conditions
- Body Weight, Body Image, Body Weight Changes, Muscle Loss
- Being tested
- Whole-food, plant-based lifestyle
- Keywords
- Body composition, Plant-based diet, Lifestyle, Physical activity, Support system, Muscle mass preservation, Fat loss
- Medical subject headings
- Body Weight, Body Weight Changes, Muscular Atrophy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-food, plant-based lifestyleBehavioural
The WFPB lifestyle program included:
- Nutrition/plant-based food (energy intake: at least 90% of whole-food, plant-based diet and ≤ 10% of energy intake from plant-based meal replacements (PBMR) and dietary supplements (e.g., vitamin B12, D, and EPA and DHA omega-3 fatty acids).
- Physical activity (habitual; organized and other).
- Support system (lectures, workshops and individual nutrition counselling, grocery shopping assistance, cooking classes, regular measurements body composition, food logging, regular medical monitoring).
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat- free mass (FFM) change
Muscle mass measured with bioimpedance analysis
Measured: Baseline, up to 6 months
Body fat mass percentage (BF %) change
Fat mass measured with bioimpedance analysis
Measured: Baseline, up to 6 months
Body mass index (BMI) change
Body mass index measured with bioimpedance analysis
Measured: Baseline, up to 6 months
Secondary outcomes (1)
Correlation between BMI, BF % and FFM and phase angle
Correlation status of variables
Measured: Baseline, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start12 Apr 2021
- Primary completion23 Apr 2021
- Study completion23 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Body WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Jakše s.p.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boštjan Jakše, Barbara Jakše s.p.
- Investigators
- Stanislav Pinter, PhD, Study chair, University of LjubljanaBostjan Jakse, PhD student, Principal investigator, University of Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849689
- Sponsor's protocol ID
- KR5
- Acronym
- WFPBmuscle
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Finucane MM, Stevens GA, Cowan MJ, Danaei G, Lin JK, Paciorek CJ, Singh GM, Gutierrez HR, Lu Y, Bahalim AN, Farzadfar F, Riley LM, Ezzati M; Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Body Mass Index). National, regional, and global trends in body-mass index since 1980: systematic analysis of health examination surveys and epidemiological studies with 960 country-years and 9.1 million participants. Lancet. 2011 Feb 12;377(9765):557-67. doi: 10.1016/S0140-6736(10)62037-5. Epub 2011 Feb 3.
PubMed 21295846Turner-McGrievy GM, Barnard ND, Cohen J, Jenkins DJ, Gloede L, Green AA. Changes in nutrient intake and dietary quality among participants with type 2 diabetes following a low-fat vegan diet or a conventional diabetes diet for 22 weeks. J Am Diet Assoc. 2008 Oct;108(10):1636-45. doi: 10.1016/j.jada.2008.07.015.
PubMed 18926128Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Kent L, Morton D, Hurlow T, Rankin P, Hanna A, Diehl H. Long-term effectiveness of the community-based Complete Health Improvement Program (CHIP) lifestyle intervention: a cohort study. BMJ Open. 2013 Nov 20;3(11):e003751. doi: 10.1136/bmjopen-2013-003751.
PubMed 24259389Johns DJ, Hartmann-Boyce J, Jebb SA, Aveyard P; Behavioural Weight Management Review Group. Diet or exercise interventions vs combined behavioral weight management programs: a systematic review and meta-analysis of direct comparisons. J Acad Nutr Diet. 2014 Oct;114(10):1557-68. doi: 10.1016/j.jand.2014.07.005.
PubMed 25257365Cava E, Yeat NC, Mittendorfer B. Preserving Healthy Muscle during Weight Loss. Adv Nutr. 2017 May 15;8(3):511-519. doi: 10.3945/an.116.014506. Print 2017 May.
PubMed 28507015
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-Food, Plant-Based Lifestyle Program Preserves Muscle Mass During Body Mass/Fat Mass Loss
- ClinicalTrials.gov ID
- NCT04849689
- Acronym / sponsor ID
- WFPBmuscle / KR5
- Conditions
- Body Weight, Body Image, Body Weight Changes, Muscle Loss
- Keywords
- Body composition, Plant-based diet, Lifestyle, Physical activity, Support system, Muscle mass preservation, Fat loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Barbara Jakše s.p.University, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 23 Apr 2021 (actual)
- Study completion
- 23 Apr 2021 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Body fat (BF) and muscle mass showed opposing association with mortality. Whole-food, plant-based (WFPB) lifestyle programs has been on the rise lately especially due to impressive health benefits.
The results of research on the effectiveness of popular weight loss diets in obese subjects showed 20 to 30% loss of lean muscle mass within to the total body weight loss, whereas in the whole-food, plant-based (vegan) diet the loss was up to 42%.
Therefore, an open research problem is to find a way how to improve body composition in an effective and healthy way (i.e., losing of excess BF while maintaining muscle mass as much as possible) but still using stric plant-based (vegan) diet.
Investigators will perform retrospective analysis of measurements of body composition and phase angle values of aprox. 200 participants who were on a WFPB lifestyle program from 2016 to 2021 and performed two successive measurements (initial and follow up (FU)), without body mass index (BMI) limitation on same medically approved and calibrated bioelectrical impedance (Tanita 780 S MA, Tokyo, Japan) and were not yet included in our previous studies. A WFPB lifestyle program were consisted of nutrition (i), (ii) physical activity and (iii) support system.
Primary outcome include the following measures: BF % and FFM and to examine the change from initial values to FU values (by gender), according BMI classification (e.g,, normal, pre-obese and obese) with subanalysis for those participants who lost up to 5 kg/more and those who lost 5 kg or more of body weight.
Detailed description
Many people are increasingly using a variety of dietary practices to manage overweight and obesity. Many people are increasingly using a variety of dietary practices to manage overweight and obesity.
Investigators will investigate the muscle mass preservation of participants on our 12-year lasting ongoing, community-based (free-living), WFPB lifestyle program during the weight/fat loss of participants.
The primary outcome is the BF %, and FFM change from initial values to FU values (for whole sample and by gender).
Secondary outcome include correlation between BMI, BF % and FFM, and PhA. Based on our experiences we believe that some participants that follow our WFPB lifestyle program may initially "afraid" to eat, according to the instructions, each meal to satiety (ad libitum). The reason lies in the typical weight loss recommendation in Western-type lifestyle that advise "eating less".
The body composition measures will include body height (BH; measured via standardized medical approved professional personal floor scale with stand (Kern, MPE 250K100HM, Kern \& Sohn, Balingen, Germany), body mass (BM), BF mass and BF %, FFM, bone mineral mass (BMM), visceral fat (VF), total body water (TBW), extracellular water (ECW), intracellular water (ICW), the ratio, whole body phase angle (PhA), all via medically approved and calibrated bioelectrical impedance Tanita 780 S MA (Tanita Corporation, Tokyo, Japan) and the use of corresponding protocols (e.g., for BMI).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will examine the body composition data of healthy adults from Slovenia (European Union) that were without preference toward plant-based diet before entering to the program. As healthy adults we mean that used data were from participants without serious comorbidities (i.e., having autoimmune or neurodegenerative disorders), physical limitations or taking medicine (for blood pressure, blood sugar or cholesterol).
Key inclusion criteria (7 listed)
- Using WFPB lifestyle program.
- Were measured on a body composition analyzer at least two successive times on the same body composition montor Tanita 780 S MA, Tokyo, Japan (at baseline, follow up) in a row at different intervals (i.e., before the start of the program and as part of follow up).
- Follow up up to 6 months
- Baseline BMI status was not an exclusion criteria.
- Data of participants that did not participate yet in our previous research.
Key exclusion criteria (4 listed)
- Being on vegan diet before joined in our program.
- Being adult (e.g., older than 18-years) before the start of the program.
- Participating in our preivous research using WFPB lifestyle program.
- Without severe chronic diseases or physical limitations (described bellow).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-food, plant-based lifestyleThe WFPB lifestyle program included: 1. Nutrition/plant-based food (energy intake: at least 90% of whole-food, plant-based diet and ≤ 10% of energy intake from plant-based meal replacements (PBMR) and dietary supplements (e.g., vitamin B12, D, and EPA and DHA omega-3 fatty acids). 2. Physical activity (habitual; organized and other). 3. Support system (lectures, workshops and individual nutrition counselling, grocery shopping assistance, cooking classes, regular measurements body composition, food logging, regular medical monitoring). | Behavioural | – |
Primary outcome
Fat- free mass (FFM) change
Time frame: Baseline, up to 6 months
Muscle mass measured with bioimpedance analysis
Body fat mass percentage (BF %) change
Time frame: Baseline, up to 6 months
Fat mass measured with bioimpedance analysis
Body mass index (BMI) change
Time frame: Baseline, up to 6 months
Body mass index measured with bioimpedance analysis
1 secondary outcome
Correlation between BMI, BF % and FFM and phase angle
Time frame: Baseline, up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Background: PubMed 21295846Finucane MM, Stevens GA, Cowan MJ, Danaei G, Lin JK, Paciorek CJ, Singh GM, Gutierrez HR, Lu Y, Bahalim AN, Farzadfar F, Riley LM, Ezzati M; Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Body Mass Index). National, regional, and global trends in body-mass index since 1980: systematic analysis of health examination surveys and epidemiological studies with 960 country-years and 9.1 million participants. Lancet. 2011 Feb 12;377(9765):557-67. doi: 10.1016/S0140-6736(10)62037-5. Epub 2011 Feb 3.
- Background: PubMed 18926128Turner-McGrievy GM, Barnard ND, Cohen J, Jenkins DJ, Gloede L, Green AA. Changes in nutrient intake and dietary quality among participants with type 2 diabetes following a low-fat vegan diet or a conventional diabetes diet for 22 weeks. J Am Diet Assoc. 2008 Oct;108(10):1636-45. doi: 10.1016/j.jada.2008.07.015.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 24259389Kent L, Morton D, Hurlow T, Rankin P, Hanna A, Diehl H. Long-term effectiveness of the community-based Complete Health Improvement Program (CHIP) lifestyle intervention: a cohort study. BMJ Open. 2013 Nov 20;3(11):e003751. doi: 10.1136/bmjopen-2013-003751.
- Background: PubMed 25257365Johns DJ, Hartmann-Boyce J, Jebb SA, Aveyard P; Behavioural Weight Management Review Group. Diet or exercise interventions vs combined behavioral weight management programs: a systematic review and meta-analysis of direct comparisons. J Acad Nutr Diet. 2014 Oct;114(10):1557-68. doi: 10.1016/j.jand.2014.07.005.
- Background: PubMed 28507015Cava E, Yeat NC, Mittendorfer B. Preserving Healthy Muscle during Weight Loss. Adv Nutr. 2017 May 15;8(3):511-519. doi: 10.3945/an.116.014506. Print 2017 May.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanislav Pinter, PhD study chair
University of Ljubljana
Bostjan Jakse, PhD student principal investigator
University of Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Weight and Body Image, run by Barbara Jakše s.p. at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat- free mass (FFM) change (time frame: Baseline, up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04849689, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.